Modern hemodialysis techniques include the surgical installation of one or more hemodialysis grafts to facilitate access to the blood flow of the patient. Currently hemodialysis patients undergo repetitive, often painful large needle punctures of their skin and underlying tissue numerous times per week to gain entry into the hemodialysis grafts. The disadvantages of this approach are numerous and well documented. Hematomas can result from uncontrolled bleeding. The graft is damaged by the multiple puncture technique leading ultimately to poor and inadequate functioning or thrombosis resulting in the need for additional operations, replacement of the graft and resultant tissue trauma. Temporary dialysis access through internal jugular veins or other venous access site further adds to patient morbidity.
Significant technical expertise and nursing care is currently required to puncture the grafts. Following dialysis and needle removal, skilled nursing staff are required to hold pressure on the graft puncture site for variable periods of time which not infrequently last up to an hour.
The present invention comprises a surface access double hemostatic valve for hemodialysis which overcomes the foregoing and other problems long since associated with the prior art. In accordance with the broader aspects of the invention, a surface access double hemostatic valve includes a first valve which is secured in the wall of a hemodialysis graft. A chamber extends from the first hemostatic valve to a second hemostatic valve which is situated at the outer surface of the skin of the patient. Access to the blood flow of the patient is achieved by inserting an instrument through the second hemostatic valve, through the chamber, through the first hemostatic valve, and into the graft.
The advantages obtained by means of the invention include the following:
1. Decreased patient suffering. PA1 2. Increased patient comfort and satisfaction. PA1 3. No needle damage to the hemodialysis graft. PA1 4. Longer lifetime of the graft. PA1 5. Decreased number of surgical procedures in the lifetime of the patient. PA1 6. Decreased cost of medical care for hemodialysis. PA1 7. Improved graft functioning with greater flow rates and decreased time in dialysis. PA1 8. Decreased nursing staff time without difficult, highly skilled punctures having to be performed. PA1 9. Decreased post-procedure time with no requirement for applying pressure at the puncture site to control bleeding. PA1 10. Further potential for improving graft design by strengthening the material used as graft punctures are no longer required. PA1 11. Decreased number of graft-related complications for patients undergoing long-term dialysis with less arm hematomas (therefore less associated vein, nerve, and arterial compression with less deep venous thrombosis and decreased potential for decreased use of the extremity), less potential for arterial embolic disease and, less exposure to the risks of anesthesia with decreased need for surgical intervention or radiologic declot intervention. PA1 12. Decreased damage to the entire venous system of the patient with decreased need for temporary access to other large caliber veins because of graft malfunction.